SUPPLY CHAIN ARTICLES
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![US flag and European union-GettyImages-2226674966]( "Can America's Retreat On mRNA Be Europe's Opportunity?")
Can America's Retreat On mRNA Be Europe's Opportunity?With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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![Engraver-wood-working-GettyImages-505274864]( "Defining The RNA Therapeutics Industry In 2023")
Defining The RNA Therapeutics Industry In 2023Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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![GettyImages-832049900]( "What Violin Making Can Teach Us About mRNA Therapeutic Quality")
What Violin Making Can Teach Us About mRNA Therapeutic QualityManaging the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.
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![GettyImages-96831350]( "“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles")
“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP PrinciplesIn the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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![comic art style speech-GettyImages-1342084200]( "“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA")
“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNAIt goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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![iStock-1095134748]( "Therapeutic Oligonucleotides: Regulations & Quality Standards")
Therapeutic Oligonucleotides: Regulations & Quality StandardsOligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
SUPPLY CHAIN VIDEOS
Advancing RNA Live panelists delve into advancements in IVT technology, homing in on innovations like bead-based purification, improved enzymes, and modular manufacturing systems.
In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.In this final segment of an Advancing RNA Live discussion, panelists April Sena, Tyler Goodwin, and Adi Nair share the most meaningful and manageable improvements the industry can be making today to upstream and downstream processes to drive down mRNA-LNP COGS.
While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues.
In this Advancing RNA Live clip, Khaled Yamout and Sanofi’s Francoise Ribes share the quality considerations that are top of mind when evaluating a novel raw material, as well as how the broader industry (i.e., standard setting organizations, suppliers, and biotechs) can arrive at a clearer understanding of a material’s quality.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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![iStock-528606286-handshake-partnership-partner-agreement]( "Transitioning From Using RUO To cGMP Chemicals For Clinical Trials")
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
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![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials")
GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
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![scientist iStock-1166567091]( "mRNA Transfection Reagent Enhances Non-Viral Gene Delivery To Stem Cells")
Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![GettyImages-2183428951-biomanufacturing]( "The Evolution Of Nucleotide Production")
From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Novel Lipid Nanoparticle Delivery Reagent And Manufacturing Workflow")
We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
